Respiratory mask

Abstract

A respiratory mask, a mould for a respiratory mask, as well as to a method for producing a respiratory mask are disclosed, in which manufacturability and usability of respiratory masks are improved. A respiratory mask is disclosed for administering a breathable gas to a patient, the respiratory mask comprising a first component formed from a flexible material and a second component formed from a material that is more rigid than the flexible material, wherein the first component is formed onto the second component by an overmoulding process.

The invention claimed is: 
     
       1. A respiratory mask configured to administer a breathable gas at a pressure that is, at least sometimes, above ambient pressure to provide Positive Airway Pressure (PAP) therapy for treating Sleep Disordered Breathing (SDB), the respiratory mask comprising:
 a frame including a socket that forms an inlet configured to receive breathable gas during use; 
 a gas washout vent; 
 a sealing cushion formed from silicone and attached to the frame; 
 a headgear assembly including a strap and configured to support the frame and the sealing cushion; 
 an elbow removably connected to the frame at the socket and configured to provide fluid communication between a conduit and the frame, the elbow being molded from a relatively rigid material, and the elbow being rotatable relative to frame; and 
 a seal constructed from an elastomer that is more flexible than the relatively rigid material of the elbow, the seal being configured to seal against the socket when the elbow is removably connected to the frame, 
 wherein the relatively rigid material of the elbow includes at least one treated portion and at least one non-treated portion, 
 wherein the elastomer is overmoulded to or with the at least one treated portion of the relatively rigid material of the elbow and secured to the relatively rigid material of the elbow via an induced adhesive bond formed between said at least one treated portion and a surface of the elastomer abutting the at least one treated portion, and 
 wherein the frame is constructed from a material that is more rigid than the silicone of the sealing cushion. 
 
     
     
       2. The respiratory mask according to  claim 1 , wherein the elbow includes a plurality of components and the at least one treated portion includes an interface between two elbow components. 
     
     
       3. The respiratory mask according to  claim 1 , wherein the seal includes a relatively long elastomer lip flexibly positionable and bendable against and adjacent the socket of the frame, and at least one relatively shorter lip positioned between the relatively long elastomer lip and an outer circumference of the elbow in use. 
     
     
       4. The respiratory mask according to  claim 3 , wherein the at least one relatively shorter lip includes two lips. 
     
     
       5. The respiratory mask according to  claim 1 , wherein the seal includes at least one relatively shorter lip extending radially between the elbow and the socket of the frame. 
     
     
       6. The respiratory mask according to  claim 5 , wherein the at least one relatively shorter lip includes two lips. 
     
     
       7. The respiratory mask according to  claim 1 , wherein the elbow includes a first circumferential flange provided towards a proximal portion of the elbow and a second circumferential flange provided towards a distal portion of the elbow, wherein the seal is provided on an outer circumference of the elbow between the first circumferential flange and the second circumferential flange. 
     
     
       8. The respiratory mask according to  claim 7 , further comprising a third circumferential flange between the first circumferential flange and the second circumferential flange, the seal being provided between the first circumferential flange and the third circumferential flange. 
     
     
       9. The respiratory mask according to  claim 8 , wherein the third circumferential flange includes a surface that engages with a shoulder of the frame. 
     
     
       10. The respiratory mask according to  claim 8 , further comprising a fourth circumferential flange adjacent the third circumferential flange, wherein the seal is provided between the third circumferential flange and fourth circumferential flange. 
     
     
       11. The respiratory mask according to  claim 7 , wherein the second circumferential flange includes a surface to engage an inboard surface of a socket of the frame. 
     
     
       12. The respiratory mask according to  claim 1 , wherein the seal includes a radial seal portion, an axial seal portion and an external seal portion. 
     
     
       13. The respiratory mask according to  claim 1 , wherein the seal includes a radial lip seal that seals against an inner surface of the socket of the frame and an axial lip seal that seals against an end face of the socket of the frame. 
     
     
       14. The respiratory mask according to  claim 1 , wherein the seal is formed on an outer circumferential portion of the elbow and is configured to seal against an inner circumferential portion of the socket when the elbow is removably connected to the frame. 
     
     
       15. The respiratory mask according to  claim 1 , wherein the seal is at least one of a syringe type seal, a blade style seal, an axial type seal structured to engage an angled face of the frame, and a seal with a generally rectangular cross-section. 
     
     
       16. The respiratory mask according to  claim 1 , wherein the at least one treated portion includes a plasma treated surface. 
     
     
       17. The respiratory mask according to  claim 16 , wherein the plasma treated surface is an atmospheric gas plasma treated surface. 
     
     
       18. The respiratory mask according to  claim 1 , wherein the at least one treated portion includes a corona treated surface. 
     
     
       19. The respiratory mask according to  claim 1 , wherein the at least one treated portion includes at least one surface treated with an adhesion promoter or solvent. 
     
     
       20. The respiratory mask according to  claim 1 , wherein the at least one treated portion includes a flame oxidized surface. 
     
     
       21. The respiratory mask according to  claim 1 , wherein the induced adhesive bond includes an adsorptive bond, a chemical bond, a diffusion bond, and/or an electrostatic bond. 
     
     
       22. The respiratory mask according to  claim 1 , wherein the relatively rigid material includes polycarbonate, polypropylene, polysulphone, phenol formaldehyde, thermoplastic, or thermoset polymer. 
     
     
       23. The respiratory mask according to  claim 1 , wherein the elastomer comprises liquid silicone rubber, solid silicone rubber and/or thermoplastic elastomers. 
     
     
       24. The respiratory mask according to  claim 1 , wherein the at least one treated portion of the relatively rigid material of the elbow and the surface of the elastomer are co-moulded. 
     
     
       25. The respiratory mask according to  claim 1 , wherein portions of said elastomer in contact with the at least one treated portion are subject to said induced adhesive bond while portions of said elastomer not in contact with said treated portion are not strongly bonded to the relatively rigid material of the elbow. 
     
     
       26. The respiratory mask according to  claim 25 , wherein said at least one treated portion is only a sub-portion of said relatively rigid material of the elbow. 
     
     
       27. The respiratory mask according to  claim 1 , wherein the at least one non-treated portion of the relatively rigid material of the elbow is not joined to the elastomer. 
     
     
       28. The respiratory mask according to  claim 1 , wherein the frame includes the gas washout vent. 
     
     
       29. The respiratory mask according to  claim 1 , wherein the elbow includes an anti-asphyxia valve. 
     
     
       30. The respiratory mask according to  claim 1 , wherein the sealing cushion is removably attached to the frame. 
     
     
       31. The respiratory mask according to  claim 1 , wherein the sealing cushion is adhesively bonded to the frame. 
     
     
       32. The respiratory mask according to  claim 1 , wherein the elbow is configured to remain connected to the frame while rotating. 
     
     
       33. The respiratory mask according to  claim 1 , wherein the elbow includes flanges configured to removably connect to the socket. 
     
     
       34. The respiratory mask according to  claim 1 , wherein a portion of the elbow extends inside of the socket when the elbow is removably connected to the frame. 
     
     
       35. The respiratory mask according to  claim 1 , wherein the elastomer has a chemical composition such that the elastomer forms the induced adhesive bond with the at least one treated portion and does not form the induced adhesive bond with the at least one non-treated portion.